Changing FDA Approval Standards: Ethical Implications for Patient Consent

Changing FDA Approval Standards: Ethical Implications for Patient Consent
Jonathan J. Darrow, Sanket S. Dhruva, Rita F. Redberg
Journal of General Internal Medicine, 8 April 2021
Open Access
The pace of new drug and medical device introductions has accelerated in recent years. In 2018, 59 novel drugs were approved in the USA, the most since 1996. A rising proportion of drugs and devices qualify for one of the US Food and Drug Administration’s (FDA) expedited programs, which allow approval based on less rigorous clinical trials. Expanded access and emergency use authorization allow access to products—such as remdesivir (Veklury) and COVID-19 vaccines—even before they are approved.

The growing array of products made available with limited evidence poses important challenges for patients and physicians. Ethical principles require that patients consent to treatment after being informed of the benefits and harms of each alternative. In routine practice, however, the consent process is often truncated, with limited presentation of alternatives, risks, and outcome data. As regulatory processes have evolved, the consent process—already criticized by some as inadequate—has changed little. We review the evolution of drug and device evidence requirements and consider the implications for informed consent…

Navigating the Informed Consent Process When Using Innovative Surgery

Navigating the Informed Consent Process When Using Innovative Surgery
Research Article
Daniel Wehrmann, Glenn E. Green, MD, Kevin J. Weatherwax, Andrew G. Shuman
Otolaryngology–Head and Neck Surgery, 24 December 2019
… Expanded access (EA), also referred to as “compassionate use,” is a Food and Drug Administration (FDA) mechanism by which patients with serious or life-threatening conditions for which there is no approved treatment may access novel investigational drugs, biologics, or medical devices. The benefits of the proposed drug/device must outweigh the risks to that patient or group of patients… Obtaining informed consent in this setting is complicated due to the conflation of clinical care and research, with each directed at different primary goals. Traditionally, clinicians are expected to solely focus on the best possible outcome for the patients they are treating. Researchers, on the other hand, are primarily focused on creating generalizable knowledge to help all patients. Of course, these goals may be more or less divergent, especially when surgeon-scientists are acting in both capacities… Surgical innovation using the EA program represents a thoughtful balance between patient/family choices, our duty to potential future patients, and the regulatory landscape in which we practice. The informed consent process represents an amalgam of standard clinical components, as well as clinical research regulations that necessarily meet a higher standard and level of scrutiny. As such, our obligations as researchers, clinicians, and our dual roles as both, highlight the need for us to uphold the highest levels of morality, ethics, and professionalism.